Nazione: Canada
Lingua: inglese
Fonte: Health Canada
BUPIVACAINE HYDROCHLORIDE
HOSPIRA HEALTHCARE ULC
N01BB01
BUPIVACAINE
2.5MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 2.5MG
BLOCK/INFILTRATION
10/20ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896001; AHFS:
CANCELLED POST MARKET
2011-08-05
PRODUCT MONOGRAPH Pr BUPIVACAINE HYDROCHLORIDE INJECTION, USP (Bupivacaine Hydrochloride) 2.5 mg/mL, 5 mg/mL and 7.5 mg/mL _Local Anesthetic_ Hospira Healthcare Corporation DATE OF PREPARATION: 5400 Cote-de-Liesse March 12, 2004 Town of Mount Royal (QC), CANADA H4P 1A5 Control # 090308 - 2 - PRODUCT MONOGRAPH NAME OF DRUG Pr BUPIVACAINE HYDROCHLORIDE INJECTION, USP (Bupivacaine Hydrochloride) 2.5 mg/mL, 5 mg/mL and 7.5 mg/mL THERAPEUTIC CLASSIFICATION Local Anesthetic ACTION AND CLINICAL PHARMACOLOGY Bupivacaine stabilizes the neuronal membrane and prevents both the generation and the conduction of nerve impulses, thereby exerting a local anesthetic action. The onset of action is rapid, and anesthesia is long lasting. The advantage of bupivacaine over other local anesthetics is in the prolonged duration of effective anesthesia. It is to be noted however, that the duration of action of a local anesthetic is dependent on a number of factors including site of injection, route of administration, concentration and volume. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is reduced. Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems. At blood concentrations achieved with therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias and to cardiac arrest. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur with bupivacaine than other local anesthetics. - 3 - Following systemic absorption, local anesthetics can produce central nervo Leggi il documento completo